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U.S. FDA Medical Device ENT Bur Requirements

FDA Medical Device Definition: An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.

Registrar Corp assists ENT Bur companies with:

  • FDA ENT Bur Establishment Registration
  • FDA ENT Bur Listing
  • FDA ENT Bur Label Requirements and Exceptions
  • FDA ENT Bur Import Information
  • FDA ENT Bur Detentions (ENT Bur Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - ENT Bur Manufacturers (ENT Bur Suppliers)
       - ENT Bur Distributors
       - ENT Bur Processors
       - ENT Bur Repackers
       - ENT Bur Relabelers
       - ENT Bur Exporters
       - ENT Bur Importers
For more information about ENT Bur Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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